ArticleJournal of research in pharmacy practice
Effect of 2 mg Versus 4 mg of Intravenous Zoledronic Acid on Bone Mineral Density at the Lumbar Spine in Indian Postmenopausal Women with Osteoporosis: A Double-blind Parallel-arm Randomized Controlled Trial.
Article in Journal of research in pharmacy practice. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed, 1 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe primary purpose was to compare the effect of 2 mg and 4 mg of intravenous zoledronic acid (ZA) on change in the lumbar spine (LS) bone mineral density (BMD) at the end of 1 year in postmenopausal women with osteoporosis. The secondary objectives were changes in BMD at the total hip and femoral neck, change in bone turnover markers (BTMs), and the incidence of new fractures.
methodsThis was a double-blind, parallel-arm, randomized control trial with an allocation ratio of 1:1 done in 70 postmenopausal women with osteoporosis.
findingsThe mean (±standard deviation) percentage increase in LS BMD at the end of 1 year was 4.86% ± 3.05% and 5.35% ± 3.73% in the 2 mg and 4 mg group, respectively. The dose of 2 mg ZA proved to be inferior to 4 mg with a noninferiority margin of 0.5%. There was no difference in BMD change at hip and BTMs between the two groups at the end of 1 year. Only one patient in 4 mg group developed two new vertebral fractures during a 12-month follow-up. Acute-phase reactions were the most common (43%) side-effects noted without any difference between the two groups (
conclusionThis study failed to show the noninferiority of 2 mg ZA compared to 4 mg ZA for change in LS BMD at the end of 1 year.
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